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First Line Therapy for High Risk Acute GVHD | Clinical Trials | Clareo Health

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First Line Therapy for High Risk Acute GVHD

Ruxolitinib in Combination With Corticosteroid as First Line Therapy for the Treatment of High Risk Acute Graft-Versus-Host Disease

NCT04061876•Chinese PLA General Hospital

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the efficacy and safety of combined Ruxolitinib With Corticosteroids as First Line Therapy for the Treatment of High risk aGVHD(acute graft-versus-host disease )

Detailed Description

Acute graft-versus-host disease (aGVHD) is treated with systemic corticosteroid immunosuppression as first line therapy. Many patients with high risk aGVHD do not respond to primary therapy, high-dose systemic corticosteroids; therefore, survival for those patients remains particularly poor. Here we determine the efficacy and safety of combined Ruxolitinib With Corticosteroids as First Line Therapy for the Treatment of High risk aGVHD.

Eligibility

Age

14 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. diagnosed with hematological diseases.
•2. Have undergone first allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor source using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies.
•3. new onset of grade II\~IV aGVHD or intermediate or high risk aGVHD (based on ST2, REG3a, other experimental objects) within 100 days post-transplantation.

Exclusion Criteria

•1. recipients of second allogeneic stem cell transplant.
•2. acute GVHD induced by donor lymphocyte infusion, interferon.
•3. received first line aGVHD treatment before enrollment.
•4. overlap GVHD syndrome.
•5. pregnant or breast-feeding women.
•6. absolute neutrophil count (ANC) \<0.5×10e9/L or platelet count (PLT) \< 20×10e9/L
•7. Serum creatinine \> 2.0 mg/dL or creatinine clearance \< 40 mL/min measured or calculated by Cockroft-Gault equation.
•8. uncontrolled infection
•9. human immunodeficiency virus infection
•10. active hepatitis b virus, hepatitis C virus infection and need antivirus treatment.
+8 more criteria

Locations (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

August 25, 2019

Primary Completion Date

August 1, 2022

Completion Date

June 30, 2023

Last Updated

November 29, 2023

Enrollment

198

ACTUAL participants

Conditions

aGVHDStem Cell Transplant Complications

Interventions

Ruxolitinib

DRUG

Corticosteroid

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 29, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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First Line Therapy for High Risk Acute GVHD

Inclusion Criteria

Exclusion Criteria

A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy

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